USP Chapter 129 Updates and SEC-MALS
USP general chapter <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies is being revised to include a SE-UHPLC method in addition the existing SE-HPLC method. Inclusion of modern chromatographic tools allows for greater flexibility in development without the need for full method validation. Ms. Peckham will share updates to USP chapter <129> focusing on SEC. Dr. Liu will focus on SEC-MALS. They will explore characterizing differences between innovator and biosimilars, including forced degradation studies.
Key learning objectives:
- Understand the recent revisions to USP<129> with a focus on size exclusion chromatography by HPLC and UPLC.
- Implication of the revised guidance and the opportunities for method modernization
- Understand complementary information gathered by adding Multi-Angle Light Scattering (MALS) detection coupled to your chromatographic system.
Who should attend:
Protein scientists involved with analytical LC method development
Presenter: Niomi Peckham (Director, Pipeline Development, US Pharmacopeia)
Ms. Peckham is the Director of Pipeline Development in USP Global Biologics. The Pipeline Development Team works with scientific experts and stakeholders to develop physical and documentary standards used to support development and quality assessment of biopharmaceuticals. She holds a Master of Science in Molecular and Cellular Biology from SUNY Stony Brook. Ms. Peckham has spent most of her career at Pfizer and Alexion Pharmaceuticals, focusing on analytical development of protein-based biopharmaceuticals.
Presenter: Hongjiang "Leo" Liu, Ph.D. (Application Scientist, Waters Corporation)
Dr. Hongjiang "Leo" Liu is an Application Scientist in the Analytical Sciences at Waters Wyatt Technology in Santa Barbara USA. He has been mainly focused on developing protein-based applications with LC-MALSthat provide more in-depth information, are easier to adopt, and are more versatile. Before joining Waters Wyatt Technology, he was a startup biotech entrepreneur and an expert-in-house at the Hult Prize Foundation. He received his Ph.D. from the University of California, Los Angeles (UCLA), where he researched and built novel designer enzymes that can capture CO2 and store them as biofuels and biopolymers with renewable electricity.
Moderator: Moderated by: Suraj Dhungana, Ph.D., MBA (Director, Americas Pharmaceutical and Life Sciences Market, Waters Corporation)
Suraj is currently the Director of Americas Pharmaceutical and Life Sciences Market for Waters Corporation. In his prior roles, he managed Waters Global Biomedical Research market and Omics Market for the Americas. Suraj holds a Ph.D. in chemistry from Duke University along with an MBA from Poole College of Management at NC State University and has completed postdoctoral trainings at the Los Alamos National Laboratory and National Institute of Environmental Health Sciences (NIEHS). He has 20+ years of experience in the areas of biotechnology focusing on human health, drug development, biomarker discovery, and bio-therapeutics characterization. Current research interest includes characterization of protein bio-therapeutics/conjugates, Oligo nucleotides and mRNA, and deliver systems.
